IXIARO®
(Japanese Encephalitis Vaccine, Inactivated, Adsorbed) Suspension for Intramuscular Injection
Visit IXIAROhcp.com, a website for travel health professionals focusing on the risk and prevention of Japanese encephalitis for travelers to Asia and endemic countries.
Indication
IXIARO® is a vaccine indicated for the prevention of disease caused by Japanese encephalitis (JE) virus, approved for use in individuals 2 months of age and older.
Important Safety Information
Contraindications
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO, any other Japanese Encephalitis Virus vaccine, or any component of IXIARO, including protamine sulfate, is a contraindication to administration of IXIARO. Because of uncertainty as to which component of the vaccine may be responsible, individuals with a history of severe allergic reaction to another Japanese Encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered.
Warnings and Precautions
IXIARO contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals. Appropriate medical care should be readily available in case of anaphylactic reaction.
Syncope (fainting) can occur in association with administration of injectable vaccines including IXIARO. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
Vaccination with IXIARO may not protect all individuals.
Immunocompromised individuals may have a diminished immune response to IXIARO.
Adverse Reactions
In infants 2 months to 15%); the most common solicited systemic adverse reactions were fever (>20%), irritability (>15%) and diarrhea (>10%). In children 1 to 20%). In children 3 to 10%). In adolescents 12 to 25%) and tenderness (>25%); the most common solicited systemic adverse reactions were headache (>20%) and myalgia (>10%).
Use in Special Populations
Pregnancy
There are no adequate and well-controlled studies of IXIARO in pregnant women, and human data available from clinical trials and post-marketing experience with IXIARO are insufficient to establish the presence or absence of drug-associated risk during pregnancy.
IXIARO® is a vaccine indicated for the prevention of disease caused by Japanese encephalitis (JE) virus, approved for use in individuals 2 months of age and older.
Important Safety Information
Contraindications
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO, any other Japanese Encephalitis Virus vaccine, or any component of IXIARO, including protamine sulfate, is a contraindication to administration of IXIARO. Because of uncertainty as to which component of the vaccine may be responsible, individuals with a history of severe allergic reaction to another Japanese Encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered.
Warnings and Precautions
IXIARO contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals. Appropriate medical care should be readily available in case of anaphylactic reaction.
Syncope (fainting) can occur in association with administration of injectable vaccines including IXIARO. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
Vaccination with IXIARO may not protect all individuals.
Immunocompromised individuals may have a diminished immune response to IXIARO.
Adverse Reactions
In infants 2 months to 15%); the most common solicited systemic adverse reactions were fever (>20%), irritability (>15%) and diarrhea (>10%). In children 1 to 20%). In children 3 to 10%). In adolescents 12 to 25%) and tenderness (>25%); the most common solicited systemic adverse reactions were headache (>20%) and myalgia (>10%).
Use in Special Populations
Pregnancy
There are no adequate and well-controlled studies of IXIARO in pregnant women, and human data available from clinical trials and post-marketing experience with IXIARO are insufficient to establish the presence or absence of drug-associated risk during pregnancy.
How to order IXIARO® (USA Healthcare Professionals)
US Private Customers:
IXIARO® Authorized Distributors of Record
US Federal Government Customers:
US Private Customers:
IXIARO® Authorized Distributors of Record
US Federal Government Customers:
Toll-free number
Fax
614-495-5555
Email
Hours of Operation
Monday to Friday
8:30 a.m. – 5:00 p.m. EST
8:30 a.m. – 5:00 p.m. EST
Medical Inquiries,
Adverse events and
Product complaints
Adverse events and
Product complaints
To report suspected adverse reactions
Contact Valneva at +1-844-349-4276 or VAERS at +1-800-822-7967 or https://vaers.hhs.gov.
Healthcare practitioners are also encouraged to report inadvertent use in pregnant women to Valneva at +1-844-349-4276.
Contact Valneva at +1-844-349-4276 or VAERS at +1-800-822-7967 or https://vaers.hhs.gov.
Healthcare practitioners are also encouraged to report inadvertent use in pregnant women to Valneva at +1-844-349-4276.
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